Mechanical Dilation of the Cervix in a Scarred Uterus (MEDICS)

MEchanical DIlatation of the Cervix in a Scarred Uterus (MEDICS)

To determine if mechanical labour induction can offer a safer and effective alternative to prostaglandins to women with previous caesarean section attempting trial of labour after caesarean (TOLAC).

Study Overview

• Status: Unknown
• Conditions: Pregnancy Related; Labor Complication; Cesarean Section; Dehiscence
• Intervention / Treatment: Device: Cervical balloon; Drug: Prostaglandins

Detailed Description

There is good evidence to show that induction of labour with a transcervical balloon compares favourably with the use of prostaglandins.The cervical balloon works by softening & stretching the cervix mechanically & stimulates the release of endogenous prostaglandins.

When compared with prostaglandins, meta-analysis have shown that for TCB induction, there is no significant different in caesarean section rates (27% vs 25%) with a reduced risk of hyperstimulation with fetal heart rate change (0.4% vs 3%). Further, when compared against induction with misoprostol, induction with a Foley catheter balloon was found to have a lower rate of caesarean section for a non-reassuring fetal heart rate (RR 0.54, 95% CI 0.37-0.79) and a fewer vaginal instrumental deliveries (RR 0.74, 95% CI 0.55-0.95) [41]. One randomized controlled trial of 824 women with no previous caesarean section comparing foley catheter balloon with a prostaglandin E2 gel demonstrated no difference in caesarean section rates & 2 cases of uterine rupture or perforation in the prostaglandin E2 arm but not in the foley catheter balloon arm. Another study involving 1859 women comparing foley catheter balloon with oral misoprostol showed no difference in caesarean section rates or complications. It was, however, noted that induction with foley catheter balloon more likely required oxytocin induction at 80.3% vs 68.4% for misoprostol.

While there were earlier concerns of an increase in infectious morbidity when using mechanical induction of labour due to the presence of a foreign body, more recent RCTs & meta-analysis have shown that there is no significant increase.

One of the main concerns for induction of labour in patients with a previous uterine scar is an increased risk of uterine rupture. One observational study of 20,095 women quoted a risk of uterine rupture in spontaneous labour to be 0.52% & in prostaglandin-induced labour to be 0.77%. Another observational study involving 33,699 women quoted a risk of 0.4% and 1% respectively. While there are also studies which suggest that there is no significant increase in the rate of uterine rupture, many professional bodies have discouraged prostaglandin-induction in women with previous scars.

Due to lower levels of hyperstimulation that could lead to fetal distress or uterine rupture, trans cervical balloon induction has found itself as a possible, safer means of induction of labour for women who are keen for vaginal birth after caesarean and are agreeable with induction. Most RCTs were small in size & did not demonstrate any uterine rupture or dehiscence. However, 2 retrospective cohort studies involving a size of 2479 & 208 women respectively showed a uterine rupture rate of about 0.5%. trans cervical balloon induction appears to be a safe method for inducing consenting women keen for vaginal birth after caesarean and this study will contribute towards this body of evidence.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 679973
    • Recruiting
    • National University Hospital, Singapore
    • Contact: Citra Mattar, Dr; Phone Number: 67725555

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Female ≥ 21 years of age at booking visit
• 1 previous uncomplicated lower segment caesarean section (CS)
• Aiming for TOLAC
• Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study
• Singleton pregnancy
• Gestational age >37 weeks
• Understands risk of TOLAC
• Eligible for induction of labour for the standard obstetric indications, including post-date or post-term pregnancies at 40-41 completed weeks of gestation
• Unfavourable Bishop's Score ≤ 5 requiring cervical priming
• Previous uterine surgery, including simple myomectomy, where there is no contraindication to TOLAC
• Reactive CTG pre-induction
• Ruptured membranes

Exclusion Criteria:

• Refusal to participate
• Women with 2 or more previous CS
• Previous classical or lower segment vertical incision, or inverted T or J incision in the previous caesarean delivery
• Previous uterine surgery with contra-indication to future TOLAC
• Maternal contraindication for vaginal delivery
• Fetal contraindication for vaginal delivery or major fetal abnormality
• Malpresentation or cord presentation
• Placenta praevia <20mm from internal os
• Chorioamnionitis
• Antepartum haemorrhage of undetermined origin AND deemed a contraindication for TOLAC
• Suspected fetal macrosomia (estimated weight on ultrasound >4kg) AND deemed a contraindication for TOLAC
• Congenital uterine abnormality
• Multifetal pregnancy
• Latex allergy or poorly-controlled asthma

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cervical Balloon; Transcervical 2-way 18 French (18F) single balloon Foley catheter, applied using a sponge-holding forceps into the cervical canal with the balloon inflated to a minimum of 30ml and maximum of 60ml with sterile water or saline [1]. This will be administered once during the study and will be retained for a maximum of 12 hours within the 24 hour study period.	Device: Cervical balloon; To assess if a cervical balloon catheter (foleys catheter) for mechanical induction of labour is comparable to prostaglandin usage for induction of labour in women who have had a previous caesarean section.; Other Names: Foley Balloon Catheter
Active Comparator: Prostaglandin; Prostaglandin E2 (Prostin®) 3mg tablet, placed high in the vaginal fornix. This will be administered per vaginum once in the first 6 hours; a second dose is administered at the discretion of the clinician / clinical team 6 hours after the first pessary, for a cumulative total of 6mg within the 24 hour study period.	Drug: Prostaglandins; Prostin will be used in the control arm.; Other Names: Prostin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in Bishops score	Assess for increase in Bishops score from baseline of <5 (Unfavourable) to >6	24hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Achieving active labour	Achieving delivery	Within 24-48hours of intervention
Number of PGE tablets required	For the prostin arm - How many tablets required, ie 1 or 2 to achieve improvement in Bishops score	Within 24-48hours of intervention
Number of times the foley catheter (cervical balloon) needs to be readjusted	Numerical number of the times the foley catheter needs to be removed, replaced or readjusted	Within 24-48hours of intervention
Mode of delivery	Successful vaginal birth after previous caesarean section, or emergency caesarean section	Within 24-48hours of intervention
Maternal complications	failed device insertion, inability to void urine following insertion, intolerance of device and early removal, vaginal bleeding after insertion of device, spontaneous membrane rupture.	Within 24-48hours of intervention
Fetal complications	fetal distress, meconium-stained liquor, malpresentation, neonatal Apgar score of <7 at 5 minutes, cord blood pH of ≤7.0, admission to NICU, neonatal hypoxic-ischaemic encephalopathy, neonatal death.	Within 24-48hours of intervention
Infectious complications	intrauterine infection, maternal sepsis (e.g. endometritis, UTI), neonatal sepsis, maternal pyrexia, onset of antibiotics	Within 24-48hours of intervention
Labour complications	uterine hyperstimulation (i.e. >5 contractions / 10mins with abnormal CTG), placental abruption, cord prolapse, postpartum haemorrhage, 3rd / 4th degree perineal tears, uterine rupture.	Within 24-48hours of intervention

Collaborators and Investigators

• Sponsor: Ministry of Health, Singapore
• Collaborators: National University Hospital, Singapore; National University of Singapore; Department of Obstetrics and Gynaecology, National University Hospital; Yong Loo Lin School of Medicine

Publications and helpful links

General Publications

• Choo SN, Kanneganti A, Abdul Aziz MNDB, Loh L, Hargreaves C, Gopal V, Biswas A, Chan YH, Ismail IS, Chi C, Mattar C. MEchanical DIlatation of the Cervix-- in a Scarred uterus (MEDICS): the study protocol of a randomised controlled trial comparing a single cervical catheter balloon and prostaglandin PGE2 for cervical ripening and labour induction following caesarean delivery. BMJ Open. 2019 Nov 6;9(11):e028896. doi: 10.1136/bmjopen-2019-028896.

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2019
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: March 13, 2018
• First Submitted That Met QC Criteria: March 19, 2018
• First Posted (Actual): March 21, 2018

Study Record Updates

• Last Update Posted (Actual): October 8, 2019
• Last Update Submitted That Met QC Criteria: October 6, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: caesarean, uterus
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications
• Other Study ID Numbers: 2018/00248

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No